FDA 483 - IntelliCell Biosciences, Inc. - December 12, 2011

The FDA Form 483 details significant deficiencies at a facility processing autologous adipose tissue (lipoaspirate) to manufacture Stromal Vascular Fraction (SVF) for intravenous or localized injection. The firm failed to establish and validate aseptic manufacturing procedures for SVF, including Ultrasonic Cavitation performed in a Laminar Flow Hood. Microbiological swabbing of the Laminar Flow Hood was only performed once between August 2010 and November 2011, despite over 100 SVF manufacturing procedures.

The firm lacks written procedures for production and process controls to ensure drug product identity, strength, quality, and purity. This includes unspecified preparation and use of a solution added to SVF, unvalidated Ultrasonic Processor parameters, and undocumented critical process parameters like "resting" time, cavitation time, probe used, centrifugation time, and solution amounts for over 100 procedures. Deviations from established procedures, such as changes in Ultrasonic Cavitation time and rod size, were not justified by a Quality Control Unit.

Laboratory controls are deficient, lacking established specifications, standards, and test procedures for SVF in-process and release criteria. SVF with varying viabilities (20-80%) was released. Validation and established working parameters for the Flow Cytometer are absent, and holding times after adding a reagent for quality control analysis are not documented.

The firm lacks written procedures for the receipt, identification, storage, and handling of components, specifically a solution used